(109 days)
VITROS AFP Reagent Pack - For the in vitro quantitative measurement of alpha-fetoprotein (AFP) in human serum to aid in the management of patients with non-seminomatous testicular cancer. VITROS AFP Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of AFP in human serum.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products AFP Reagent Pack, VITROS Immunodiagnostic Products AFP Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS AFP assay). The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. Common reagents used by the VITROS System in each assay.
Here's an analysis of the provided text regarding the VITROS AFP assay's acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in the typical "pass/fail" format. Instead, it demonstrates "substantial equivalence" to a predicate device. The performance is primarily shown through a correlation study and analytical performance characteristics.
| Acceptance Criterion (Implicit) | Reported Device Performance (VITROS AFP assay) |
|---|---|
| Substantial Equivalence to Predicate Device (Abbott AxSYM AFP) | Correlation: |
| VITROS AFP assay = 0.889 x [AxSYM AFP assay] + 2.60 (IU/mL) | |
| with a correlation coefficient of 0.991. | |
| Clinical Utility (Serial Monitoring): | |
| "The serial monitoring study demonstrated the clinical utility of the VITROS AFP assay as an aid in the management of patients with non-seminomatous testicular cancer." | |
| Distribution of Results: | |
| "In clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases, the VITROS AFP assay exhibited distribution results that parallel expected distributions for these patient types." | |
| Analytical Sensitivity (Specificity, Precision, Dilution) | "tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS AFP assay package insert for VITROS AFP assay results." (Specific values are not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "samples from serially monitored patients diagnosed and treated for testicular cancer" and "patient specimens covering the normal, therapeutic and diagnostic range." It also refers to "clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases."
- Specific sample sizes are NOT provided in this summary.
- Data Provenance: The data appears to be retrospective as it compares the new device results with those from an already approved predicate device using existing "patient specimens." The country of origin is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This is a lab assay, not a diagnostic imaging device that typically uses expert readers for ground truth.
- Not applicable in the context of this in vitro diagnostic (IVD) assay for AFP levels. The "ground truth" for an IVD assay typically refers to the accuracy of its measurement of the analyte. In this case, the predicate device (Abbott AxSYM System AFP) served as the reference standard for the comparison.
4. Adjudication Method for the Test Set:
- Not applicable for this type of IVD assay. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there can be disagreement among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers are involved. The VITROS AFP assay is an automated in vitro diagnostic test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in essence, the study is a standalone performance assessment. The VITROS AFP assay is an automated system designed to quantitatively measure AFP levels. Its performance is evaluated directly against a predicate device without human interpretation being the primary variable. The results are compared directly to the predicate device's output.
7. The Type of Ground Truth Used:
- The primary "ground truth" or reference standard used for comparison was the predicate device, the Abbott AxSYM System AFP assay. The performance of the VITROS AFP assay was evaluated based on its correlation and agreement with readings obtained from this established, FDA-approved device. Additionally, the clinical utility was assessed through "serial monitoring" of actual cancer patients, implying clinical outcomes were considered in relation to AFP levels.
8. The Sample Size for the Training Set:
- Not applicable/Not explicitly stated. This document describes a traditional medical device (an immunoassay kit and system), not a machine learning or AI-driven device that requires a distinct "training set" in the common AI sense. The development of such assays involves extensive R&D and calibration, but not typically a separate "training set" as defined for AI models.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not explicitly stated. As this is not an AI/ML device, the concept of a training set ground truth doesn't directly apply in the same way. The assay's analytical characteristics (calibration, sensitivity, etc.) are established through laboratory procedures and reference materials.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.